Method and system for dispensing, tracking and managing pharmaceutical trial products

ABSTRACT

A new and improved method of dispensing, tracking and managing pharmaceutical product samples by communicatively linking prescribers and pharmacies to a central computing station. The method entails utilizing product trial media that is exchanged for actual pharmaceutical product. The media is encoded with information that identifies a particular pharmaceutical trial product, such as by magnetic encoding similar to that used with credit cards. The media is distributed to participating medical doctors or prescribers who then activate the media via the central computing station. The prescriber then transfers the activated media to patients who then present the media to participating pharmacies. Before filling the pharmaceutical trial product identified by the media, the pharmacy validates the media via a link with the central computing station. Then, the pharmacy dispenses the prescribed pharmaceutical trial product. The central computing station also includes a database that records data related to the use of the media so that all pharmaceutical trial products can be accounted for.

FIELD OF THE INVENTION

The present invention relates generally to the distribution ofpharmaceutical product samples and more particularly to an improvedmethod of dispensing, tracking, and managing pharmaceutical productsamples by communicatively linking prescribers and pharmacies to acentral computing station.

BACKGROUND OF THE INVENTION

In the pharmaceutical industry, the primary method for product promotionof ethical products is the use of outside sales representatives. Companysales representatives target specific physicians and detail the featuresand benefits of particular pharmaceutical products. Pharmaceuticalmanufacturers have documented that the most effective method of productpromotion involves providing pharmaceutical product samples toprescribers of the products who then pass along the product samples topatients. Physicians therefore receive numerous quantities ofpharmaceutical product samples for purposes of conducting patienttrials. These trials enable physicians to determine the effectiveness ofcertain drugs in certain patients for certain diseases, as well as todetermine patients' tolerance of the drugs and their compliance withdrug administration directions.

A responsibility of the Food & Drug Administration (FDA) is theregulation of pharmaceutical product samples. The PDMA (PharmaceuticalDrug Manufacturing Act) Act of 1987 requires pharmaceuticalmanufacturers to track and account for product samples distributed bysales representatives to prescribing physicians. Pharmaceuticalmanufacturers are required to account for all sample productinventories, as well as the time, location, and specific physicians whoreceive promotional samples. Pharmaceutical sales representatives arerequired to record receipts of product samples, adjustments to sampleinventories, and distribution of product samples, and to report any lossor theft of product samples. Additionally, PDMA warehousing requirementsdictate inventory storage methods and locations both withinpharmaceutical companies themselves and for outside pharmaceutical salesrepresentatives.

However, it is often the case that accountability for pharmaceuticalproduct samples ends when the samples reach the physicians. Mostphysicians do little to account for their inventories of productsamples. Rather, physicians tend to distribute pharmaceutical productsamples to patients much more informally than retail pharmacies, keepingfew if any records and often not even counting the precise number ofproduct samples given to patients.

The PDMA's accountability requirements increase pharmaceuticalmanufacturers' expenses for promoting and distributing product samplesas well as the complexity of administering sampling programs. Ascompetition within the pharmaceutical industry increases, costsassociated with product samples place an increasingly greater burden onthe pharmaceutical manufacturers. Pharmaceutical manufacturers aretherefore attempting to reduce expenses and maintain acceptable profitswhile incorporating the PDMA's new requirements into establishedpromotional practices.

Although product samples are an extremely effective promotional tool,the manufacturing of drug product samples in addition to normallypackaged drug products has proven to be increasingly costly.Pharmaceutical product samples are typically elaborately and expensivelypackaged and are extremely bulky compared to normally packaged drugproducts. Pharmaceutical manufacturers must utilize separate productsample packaging lines to specially package drug product samples.Distribution of product samples requires delivery via separate carriersand distribution routes. In addition, drug product samples are typicallywarehoused separately from normally packaged drug products.

Because the current climate in the pharmaceutical industry prohibits theunrestrained shifting of costs to final consumers, pharmaceuticalmanufacturers have taken several new approaches to reducing costsassociated with promoting product samples. Nevertheless, pharmaceuticalmanufacturers are attempting to maintain the marketing advantages ofusing sales representatives to distribute product samples.

One cost-reducing approach that pharmaceutical manufacturers haveattempted is the distribution of sample vouchers to prescribingphysicians, retail pharmacies, and pharmaceutical sales representatives.With this approach, instead of giving drug product samples directly topatients, physicians give the patients vouchers for the drug productsamples. The vouchers may then be redeemed at retail pharmacies for theactual drugs. Alternately, the patients may receive cash or creditrebates at the pharmacies.

Another cost-reducing approach that pharmaceutical manufacturers haveattempted is the distribution of product samples via mail order. Withthis approach, pharmaceutical sales representatives provide prescribingphysicians with request authorization forms. Physicians then use theforms to authorize deliveries of product samples directly to physicianoffice from third-party pharmaceutical supply warehouses.

The above new approaches to distributing pharmaceutical product sampleshave not met with substantial and universal acceptance. All of theseapproaches lack an effective, efficient and practical system fordistributing the trial or sample products to patients and at the sametime recording pertinent data, which is easily accessible, relating toprescribing and dispensing the pharmaceutical trial products.

SUMMARY AND OBJECTS OF THE INVENTION

The present invention entails a system and method for managing andtracking the distribution of pharmaceutical trial or sample products byutilizing medical prescribers and pharmacies. Instead of the medicalprescriber directly delivering pharmaceutical trial products topatients, the present system and method contemplates the prescriberprescribing a pharmaceutical trial product to a patient and the fillingof that prescription by a participating pharmacy. This method andprogram is managed through a central computing station that iscommunicatively linked to terminals located at participating prescriberand pharmacy sites. This system, as will be discussed in greater detailbelow, manages, tracks and records selected transactions involving theparticipating prescribers, pharmacies and patients.

To identify various pharmaceutical trial products, the system utilizes amedium, such as a magnetic card, which is encoded with specificinformation that particularly identifies a certain pharmaceutical trialproduct. Encoded media is then distributed to participating medicaldoctors or prescribers. Once the encoded product trial media is receivedby the prescribers, the prescribers then activate the selected producttrial media. Activation is accomplished, in part at least, by utilizinga prescriber terminal to communicatively link the selected product trialmedia with the central computing station or host. Once the product trialmedia has been activated, the prescriber then transfers the activatedproduct trial media to patients. The patients then present the activatedproduct trial media to participating pharmacies. Prior to filling theprescriptive pharmaceutical trial product identified by the media, thepharmacy engages in a procedure designed to validate thepatient-presented pharmaceutical trial media. To validate the presentedproduct trial media, the pharmacy communicatively links the presentedmedia to the central computing station via the pharmacy terminal. Aftermaking selected verifications, the central computing station validatesthe presented product trial media. Validation results in the pharmacydispensing the pharmaceutical trial product identified by the presentedmedia.

Prior to activation and validation, the system and method of the presentinvention requires that the participating pharmacies and prescribersestablish "authorization", that is that they are in fact authorizedparticipants in the pharmaceutical trial product distribution program.

After validation and dispensing, a database associated with the centralcomputing station will have recorded the activation and validationtransactions and other data related thereto. Based on the recorded data,audit and accounting procedures can follow. Particularly, dispensedpharmaceutical trial products can now be replaced at the pharmacy level,via wholesalers, by simply replenishing quantities of pharmaceuticalproducts dispensed by the participating pharmacies. Replenishment of thepharmaceutical trial product can be carried out and managed inaccordance with the records of the database. Moreover, it iscontemplated that participating pharmacies will be remunerated with adispensing fee that can be determined based on the records of thedatabase associated with the central computing station.

It is therefore an object of the present invention to provide a moreeffective and efficient process for managing the distribution ofpharmaceutical trial products.

Another object of the present invention is to provide a system andprocess for the distribution of pharmaceutical trial products thatinherently includes "checks and balances" and which in the end isdesigned to ensure integrity and accountability throughout the entireprocess.

It is also an object of the present invention to provide a system andprocess for distributing pharmaceutical trial products that is more costeffective than conventional processes, especially processes that requirespecial trial or sample packaging.

It is also an object of the present invention to provide a system andmethod for managing the distribution of pharmaceutical trial productsthat provides for the computerized recordation of selected transactionssurrounding the prescription and distribution of pharmaceutical trialproducts.

Another object of the present invention is to provide an improved methodof distributing pharmaceutical product samples that eliminates the needfor pharmaceutical manufacturers to specially package drug productsamples differently from normally packaged drugs, thereby cutting costsassociated with manufacturing, storing, and distributing drug productsamples.

A further object of the present invention is to provide an improvedmethod of distributing drug product samples while maintaining the roleof outside pharmaceutical sales representatives in promoting andmarketing drug products.

Other objects and advantages of the present invention will becomeapparent and obvious from a study of the following description and theaccompanying drawings, which are merely illustrative of such invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of the system of the presentinvention for managing the distribution of pharmaceutical trialproducts.

FIG. 2A is a front side view of the pharmaceutical trial product mediathat forms a part of the present invention.

FIG. 2B is a back side view of the pharmaceutical trial media.

FIG. 3A is a front side view of the authorization media that forms apart of the present invention.

FIG. 3B is a back side view of the authorization media.

FIGS. 4A-4B depicts a flow chart that shows the basic steps entailed indistributing, tracking and managing pharmaceutical trial productdistributed in accordance with the present invention.

FIG. 5 is a flow chart that depicts the basic steps entailed in terminalinitialization, whether it be at the prescriber or pharmacy level.

FIGS. 6A-6D depicts a flow chart that shows the basic steps involved inthe prescribers activating pharmaceutical trial media.

FIGS. 7A-7E depicts a flow chart that shows the basic steps involved invalidating activated product trial media and dispensing pharmaceuticaltrial products in response to the validation of product trial media.

DETAILED DESCRIPTION OF THE INVENTION

With further reference to the drawings and particularly to FIG. 1, thesystem utilized for carrying out the present invention is shown thereinand indicated generally by the numeral 10. System 10 includes a centralcomputing station 12 that has associated therewith a database forstoring data and information communicated to the central computingstation 12 during various steps or phases of the pharmaceutical trialproduct distribution process. As will be appreciated from subsequentportions of this disclosure, the present invention contemplates theutilization of participating medical doctors or prescribers andpharmacies to effectuate the distribution of pharmaceutical trialproducts. In order to communicate with the central computing station 12,each participating prescriber and pharmacy is provided with a terminalcommunicatively linked with the central computing station 12. Therefore,it is appreciated that the system 10 of the present invention willinclude prescriber terminals 14 located at various participatingprescriber sites and pharmacy terminals 16 located at variousparticipating pharmacy sites. Both the prescriber terminals 14 and thepharmacy terminals 16 are capable of communicatively linking encodedmedia with the central computing station 12 where the encodedinformation associated with the media can be recorded in the associateddatabase. Various types of communication terminals can be utilized atprescriber and pharmacy sites. However, as will be appreciated fromsubsequent portions of this disclosure, one such type of terminal is aconventional magnetic card reader that is adapted to accept magneticcards and to read or interpret encoded information provided thereon andto communicate with the central computing station 12.

System 10 further includes what is referred to as a pharmaceuticalproduct trial media that in FIG. 1 is indicated by the numeral 18. Aswill be appreciated from subsequent portions of the disclosure, theproduct trial media 18 identifies and is associated with a particularpharmaceutical trial product and is transferred and passed betweenparticipating prescribers, patients and pharmacies. The product trialmedia 18 is particularly encoded with pertinent information thatidentifies a particular pharmaceutical trial product and is designed tobe compatible with the prescriber and pharmacy terminals 14 and 16. Inparticular, prescriber and pharmacy terminals 14 and 16 are capable ofreading the product trial media 18 and communicating encoded informationassociated therewith to the central computing station 12 for processingand recordation.

Although the type and quantity of encoded information on the producttrial media 18 can vary, it is contemplated that each individual producttrial media 18 would be encoded with at least the following information:

a) media identification number;

b) product identification number;

c) product name;

d) product form;

e) product size;

f) product quantity;

g) media type;

h) a series of manufacturer I.D. numbers;

i) a date range

In addition, as illustrated in FIGS. 2A and 2B, each individual producttrial media 18 will have printed or embossed thereon certain identifyinginformation such as:

a) pharmaceutical manufacturer's name;

b) product name (trade name, generic name);

c) product form;

d) product size;

e) product quantity;

f) media identification number;

g) prescriber, patient and pharmacy signature areas;

h) prescriber and pharmacy approval code areas

The product trial media 18 can assume various tangible forms. However,in the example illustrated in FIGS. 2A and 2B and discussed herein, theproduct trial media 18 is in the form of a conventional magnetic cardwhich again is designed to be compatible with a READ-ONLY magneticreader terminal located at prescriber and pharmacy sites.

Finally, the system 10 of the present invention includes authorizingmedia indicated by the numeral 20 that is distributed to participatingprescribers and pharmacies. As with the product trial media 18, theauthorizing media 20 can be in various tangible forms and in the exampleillustrated herein, the authorizing media assumes a READ-ONLY magneticcard form that is compatible with the prescriber and pharmacy terminals14 and 16. Each individual authorizing media specifically identifies aparticipating prescriber or pharmacy. In the case of prescriberauthorizing media, the same would be encoded with various identifyinginformation such as:

a) the prescriber's name,

b) prescriber's medical identification number,

c) prescriber's control I.D. number,

d) prescriber location identification.

In the case of pharmacy authorizing media, the same would includeencoded information specific to and identifying a particularparticipating pharmacy. The encoded information on such a pharmacyauthorizing media would include identifying information such as:

a) pharmacy name,

b) name of individual pharmacists associated with the identifiedpharmacy,

c) pharmacy control identification number, and

d) pharmacy location identifier.

Also, as illustrated in FIGS. 3A and FIGS. 3B, the authorization media20 includes printed or embossed information thereon such as prescriberor pharmacy I.D. number, pharmacy or prescriber name, card expirationdate, and space for the signature of a physician or pharmacist.

As will be discussed in more detail later, the authorizing media 20 iscompatible with the prescriber and pharmacy terminals 14 and 16 andconsequently, encoded identifying information associated with theindividual authorizing media 20 can be reviewed and verified by thecentral computing station 12 prior to the participating prescribers andpharmacies having access to the central computing station. Theauthorizing media 20 enables the system and the central computingstation 12 in particular to verify that prescribers and pharmaciesattempting to enter the system and network are in fact authorized to doso and are in fact authorized participants in the pharmaceutical trialproduct distribution program of the present invention. See FIGS. 4A-4B.

The present invention entails a pharmaceutical trial productdistribution method or process where pharmaceutical trial products areactually prescribed by a participating medical doctor or prescriber andnot directly delivered to the patient by the prescriber as isconventional practice today. Once the pharmaceutical trial product hasbeen prescribed, the patient then proceeds to a participating pharmacywhere the prescription for the trial or sample pharmaceutical product isfilled. Prescriber and pharmacy transactions are all monitored andrecorded by the central computing station 12. Periodically, theparticipating pharmacies are compensated for the trial product dispensedand the services performed. Compensation would typically includereplenishment of dispensed trial product through a wholesaler plus adispensing fee, all of which is established by recorded transactionswithin the central database.

It is contemplated that the present system and method for distributingpharmaceutical trial products would be managed by an independent entityreferred to as a program manager and that a number of pharmaceuticalmanufacturers would join together in a consordium or the like toparticipate in the pharmaceutical trial product distribution program,all of which would be administered and managed by the program manager.However, it is to be appreciated that the present pharmaceutical trialproduct distribution system and method can be carried out in other formsincluding a program administered and managed totally by a singlepharmaceutical manufacturer.

In developing and implementing the pharmaceutical trial productdistribution program of the present invention, participating prescribersand pharmacies must be established. In this regard, it is contemplatedthat the program manager in cooperation with participatingpharmaceutical manufacturers or suppliers, sometimes referred to aspharmaceutical members, ientify certain prescribers and pharmacies thatare authorized to participate in the program. Thereafter, the programmanager issues specific authorizing media 20 to each of the prescribersand pharmacies authorized to participate in the program. Note that eachauthorizing media 20 is specifically encoded to identify a certainprescriber or pharmacy as well as the physical location or locations ofthat prescriber or pharmacy. In addition to the authorization media 20,prescriber terminals 14 and pharmacy terminals 16 are also delivered tothe participating prescribers and pharmacies.

The prescriber and pharmacy terminals 14 and 16 are transaction-basedcommunication units provided with both an EPROM chip and random accessmemory (RAM) for application operation. Each terminal is electricallypowered and adapted to communicate with the central computing station orhost 12 through a conventional telephone system. A user keypad havingboth function keys and a ten-number keypad are incorporated into eachterminal. Application, prompt and approval instructions are communicatedthrough an LED display that forms a part of each terminal.

The EPROM chip of each terminal is provided with a series of data fieldsthat are used in a terminal initialization procedure that is designed toverify that a respective terminal is properly located physically and isunder the control of an authorized and participating prescriber orpharmacy. In the way of example, the data fields of the EPROM chip couldinclude: terminal serial number, prescriber or pharmacy identification,location or locations (physical address) for the participatingprescriber or pharmacy assigned to that terminal, and location fax andtelephone number. In addition, the EPROM chip of each terminal wouldinclude a check digit/analog code matrix used in establishing theauthenticity of the terminal.

Now, turning to the RAM of the respective terminals, it is appreciatedthat the capacity of the RAM may vary but it is contemplated a storagecapacity of 32K bytes would be sufficient to handle downloadedapplication programming from the central computing station 12. Datafields for the RAM may include a series of server (central computerstation) phone numbers, a check digit/analog code index field, checkdigit/analog code multiplier-divisor, check digit/analog answerer, checkdigit/analog code formula, and system date and time.

The above discussion deals generally with the basic prescriber andpharmacy terminals 14 and 16 that are contemplated to be used incarrying out the pharmaceutical trial product distribution method andprogram of the present invention. Details of the construction andprogramming of the terminals are not dealt with herein because such isnot per se material to the present invention and further, because suchterminal designs are well appreciated by those skilled in the art andare in fact commercially available. While various types of terminals maybe employed by participating prescribers and pharmacies, it iscontemplated that a terminal design of a conventional magnetic cardreader would be efficient and cost effective for the presentpharmaceutical trial product distribution program.

Initially, various pharmaceutical members distribute individual producttrial media 18 to participating medical doctors or prescribers. Thisdistribution can be carried out by sales representatives of thepharmaceutical members. At the same time, the program manager(administrator of the pharmaceutical trial product distribution program)may distribute both terminals and authorizing media 20 to bothparticipating medical doctors and pharmacies. It is appreciated thatprior to the initiation of the program and in fact on an ongoing basis,the database associated with the central computing station 12 is loadedwith data corresponding to the distributed product trial media 18 andauthorization media 20 as well as data that identifies each individualterminal to be delivered to participating prescribers and pharmacies.Such is important in carrying out the various integrity checks that willform a part of the pharmaceutical trial product distribution program ofthe present invention.

Prior to entering the system and participating in the pharmaceuticaldistribution program, each participating prescriber and pharmacy mustproceed through a terminal initialization process. This terminalinitialization process, as illustrated in FIG. 5, is designed todiscover and identify unauthorized participants and to generally preventunauthorized use of the system.

To initialize a terminal, the prescriber or pharmacy connects theterminal to an AC power outlet and a conventional phone line. Once theterminal is placed in an "on" state, the prescriber or pharmacy pressesa "setup" function key. The terminal then automatically responds andrequests information pertinent to the data fields of the EPROM chip. Inthe way of examples, the terminal requests the user to input into theissued terminal the terminal serial number, practice name or pharmacyoperating from the location of the terminal, the physical address of thelocation of the terminal, location communication telephone number,location business telephone number and location fax number.

Next, and still as a part of the terminal initialization process, theterminal requests that the prescriber or pharmacy user enter its issuedauthorization media 20. In the case of a magnetic card media and reader,the prescriber or pharmacy simply swipes its authorization media card 20through a magnetic card reader and encoded data on the authorizationmedia card 20 is recorded in the RAM of the terminal.

Thereafter, the terminal automatically dials and connects to a terminalinitialization service that forms a part of the central computingstation 12. The initialization service then uploads all data from theterminal into the database of the central computing station 12 includingdata recorded on the EPROM chip and information previously encoded onthe authorization media 20 and now stored in the RAM of the terminal.

Based on independently entered reference data previously entered intothe database of the central computing station, the data uploaded fromthe terminal during this initialization process can be checked againstthe reference data already stored in the database of the centralcomputing station. At this point, the central computing station canverify whether a certain serial number terminal is properly coupled witha certain physical location and with a certain prescriber or pharmacy.If all relevant data uploaded from the terminal does not correspond tothe reference data then the initialization process is failed and accessto the system and program is denied.

In the specific initialization method being discussed herein, the abovedoes not complete the total initialization process. After passing theabove, the individual prescriber or pharmacy is requested to enter apersonal identification code, commonly referred to as a PIN. Thepersonal identification code is furnished confidentially to theparticipating prescribers and pharmacies through the program manager andcan be permanent or temporary. If temporary, the user will besubsequently requested to enter a personally devised code which becomesthe user's permanent identification or PIN code. In any event, after thecentral computing station has requested entry of the user's personalidentification code, the participating prescriber or pharmacy thenenters the personal identification code into the system database and thecentral computing station then verifies the personal identification codeand cross-checks the same with respect to uploaded terminal data, thatis, data found on the EPROM chip and the terminal's RAM. If the personalidentification code entered is determined to be an invalid personalidentification code for any reason, the prescriber or pharmacy is deniedaccess to the system. On the other hand, if the personal identificationcode is deemed to be valid then the central computing station indicateson the terminal's display "downloading application". At this time, thesystem's application is then downloaded into the terminal's RAM storage.Thereafter, the terminal displays "download complete" and this completesthe terminal initialization process. The initialized terminal is thenready to be used on a periodic basis in the pharmaceutical trialdistribution program of the present invention. Not that this sameinitialization process is carried out for both participating prescribersand pharmacies.

The product trial media 18 delivered to the participating prescribersarrive in an unactivated state. That is, the product trial media in anunactivated state cannot be validated by a participating pharmacy andaccordingly, pharmaceutical trial product identified by that mediacannot be dispensed. In the method of distributing pharmaceutical trialproduct of the present invention, the participating prescribers actuallyactivate the product trial media through a procedure where the producttrial media is communicatively linked with the central computing stationor host 12 via a prescriber's terminal. See FIGS. 6A-6D which show aflow chart that depicts the basic steps involved in the activationprocess. However, before any unactivated product trial media can beactivated by a prescriber, the prescriber must establish authorization.This can be carried out in a variety ways. In one embodiment of thepresent invention, activation of product trial media 18 is conditionedfirst upon the prescriber evidencing a valid authorization media. Thisis accomplished by the prescriber's terminal reading the prescriber'sauthorization media 20. Encoded information associated with theprescriber's authorization media 20 is recorded within the RAM of theprescriber's terminal. In particular, the terminal records theprescriber's identification number associated with the prescriber'sauthorization media 20. At that point, the terminal requests theprescriber to enter the prescriber's personal identification code. Next,the terminal requests the prescriber to enter the quantity (number) ofpharmaceutical trial media that the prescriber desires to activate.Thereafter, the prescriber enters into the keyboard of the prescriberterminal the numeric quantity of product trial media 18 to be activatedby the system. The prescriber terminal then prompts the prescriber tocommunicatively link the product trial media to be activated with theprescriber's terminal. In cases where the product trial media 18 assumesthe form of magnetic cards for example, the prescriber simply swipes theproduct trial cards to be activated through a card reader-type terminal.One by one, the prescriber swipes the product trial media to beauthorized through the prescriber's terminal.

As each product trial media is read by the prescriber's terminal, anauthenticity check is made by the terminal. Specifically, theprescriber's terminal authenticates each product trial media read intothe terminal. While various forms of authentication can be performed, inthe present method, authenticity is established by the prescriber'sterminal checking the product trial media I.D. and verifying that avalid answer results from the various check digit/analog code fieldsstored in the terminal. If the product trial media is deemed authentic,then the prescriber's unit then displays "product trial media valid". Ifthe prescriber terminal determines that the product trial media is notvalid, the terminal indicates such and the product trial media is notactivated.

Once the prescriber has completed the activation of a certain number ofproduct trial media the prescriber terminal dials a central computingstation 12. At this point, the prescriber terminal uploads storedinformation corresponding to the prescriber authorization media and theprescriber identification code to the central computing station 12. Thecentral computing station 12 validates the prescriber authorizationmedia and the personal identification code. Once this validation hasbeen established the central computing station uploads all of theproduct trial media information previously read into the prescriber'sterminal during the present activation procedure. It is at this timethat the central computing station 12 approves the "activation" of theentered product trial media and issues a specific approval code to theprescriber. The prescriber then records the prescriber approval codeonto the face of the respective individual product trial media justactivated. Once certain product trial media 18 has been activated, thecentral computing station 12 denotes in its associated database thatcertain product trial media 18 has been activated, the activation date,and the identity of the prescriber activating the product trial media.The prescriber then appropriately stores the activated product trialmedia 18.

To dispense the pharmaceutical trial product represented by theactivated product trial media, the prescriber signs the product trialmedia and delivers the same to a participating patient. The patient inturn presents the activated product trial media to a participatingpharmacy for the purpose of filling the trial product prescription ofthe prescriber.

Prior to actually filling the pharmaceutical trial prescription, theparticipating pharmacy, like the prescriber, must establishauthorization. First, like the prescriber, the pharmacy terminal issubjected to the initialization test discussed above. This basicallyestablishes that the issued terminal to the participating pharmacy is infact the correct terminal, is properly physically located, and isassociated with the assigned pharmacy. Again, this initializationprocedure, as discussed above, is not contemplated to be a dailyprocedure but is only a basic initialization step for the participantutilizing the terminal and the system.

However, before the pharmacy can fill the prescriptive trial product ofany presented product trial media 18, the product trial media must besubjected to a "validation" procedure. The "validation" procedure isbasically illustrated in FIGS. 7A-7B. Essentially, this validationprocedure establishes that the presented product trial media 18 isauthentic, still within an acceptable date range, has been activated bya prescriber, and has not previously been validated. Once validation isestablished for any presented product trial media, then theparticipating pharmacy can issue the prescriptive trial pharmaceuticalproduct to the patient.

Details of the validation process will not be dealt with here in greatdetail because pharmaceutical "validation" of product trial mediaparallels prescriber "activation" of the product trial media justdescribed. That is, "validation" by the participating pharmacy entailssteps and procedures that are similar in function and result as thesteps and procedures engaged in by the prescriber in activating certainproduct trial media. But briefly, the validation step entails theparticipating pharmacy establishing authorization. This can be carriedout in a variety of ways. However, in the process contemplated herein,the participating pharmacy would communicatively connect itsauthorization media 20 with the pharmacy terminal and after establishinga valid authorization media the participating pharmacy would enter itspersonal identification code. Thereafter, the terminal prompts thepharmacy to read the presented product trial media 18 into the terminal.As an individual product trial media is read into the pharmacist'sterminal, the terminal first checks for complete authenticity of thepresented product trial media 18. Like with the prescriber, theidentification of the media is checked, the date range of the media ischecked and the terminal seeks a valid answer from the checkdigit/analog code fields. If authenticity is not established, it followsthat the participating pharmacy cannot dispense correspondingpharmaceutical product. However, if authenticity is established then thepharmacies' terminal dials the central computing station and data andinformation from the pharmacies' authorization media and personalidentification is uploaded to the database of the central computingstation 12. The central computing station establishes that the uploadedinformation is valid and then information from the pharmacies' terminalrelated to the presented product trial media 18 is uploaded to thecentral computing station. Assuming full validation, the centralcomputing station issues a pharmacy approval code and the pharmacyrecords that approval code on the actual presented product trial media18. In addition, both the pharmacy and the patient sign the nowvalidated product trial media 18. Once validation is established thepharmacy then dispenses pharmaceutical trial product authorized by thatvalid product trial media and permanently stores the validated media. Atthe same time, the central computing station 12 records the fullvalidation data within its database by showing that a particular producttrial media 18 has been validated, the date of such validation, and theidentity of the pharmacy validating the same.

Obviously, the database associated with the central computing station 12will possess a full record of all transactions of the program includingactivations and validations. Importantly, the recorded transactionsreveal the dispensing activities of each participating pharmacy. Thisserves as a basis for replenishing to the participating pharmacypharmaceutical products dispensed in the present program and for thepayment of dispensing these to the participating pharmacies. Typically,the pharmaceutical trial product to be replenished can be replenishedthrough wholesalers that serve the participating pharmacies.

A wealth of data can be discerned from the central computing database.For particular pharmaceutical members, data representing the identity ofproduct and the quantity of a particular trial product prescribed anddispensed over a selected period of time is obviously readily available.More detailed data and records representing the specific activities ofparticular prescribers or pharmacies is also available. In the end, awide variety of reports can be generated from the database. Thesereports can be so extensive and so detailed that the participatingpharmaceutical members can study and evaluate "cause and effect" basedon the recorded data.

In summary, the present method of tracking and managing the dispensingof pharmaceutical trial products centers around the utilization of agroup of authorized prescribers and pharmacies and a centralizedcomputing station that is specifically linked to the participatingprescribers and pharmacies. Product trial media capable of beingexchanged at a pharmacy for pharmaceutical trial product is delivered inan unactivated state to participating prescribers. After establishingauthorization, the prescriber through a remote terminal and the centralcomputing station "activates" certain product trial media. Onceactivated, the product trial media is capable of being prescribed orexchanged for a pharmaceutical trial product at a participating pharmacysite. The activated pharmaceutical trial media 18 is then delivered to apatient and the patient in turn presents the same to a participatingpharmacy. The pharmacy must establish authorization to participate inthe system and thereafter the presented activated product trial media isauthenticated by the central computing station and is deemed valid.Next, the pharmacy dispenses the pharmaceutical trial product identifiedby that media. Thereafter, an audit and accounting function is performedbased on the database associated with the central computing station.Accordingly, participating pharmacies can be compensated for the actualdispensed pharmaceutical product and for dispensing services performed.

The present method and program has been described as being carried outby utilizing magnetic cards and magnetic terminal readers. However, itis appreciated that other media forms and terminals could be utilized tocarry out the basic method of tracking and managing the distribution ofpharmaceutical trial products.

The present invention may, of course, be carried out in other specificways than those herein set forth without parting from the spirit andessential characteristics of the invention. The present embodiments are,therefore, to be considered in all respects as illustrative and notrestrictive, and all changes coming within the meaning and equivalencyrange of the appended claims are intended to be embraced therein.

What is claimed is:
 1. A method of dispensing, tracking and managingpharmaceutical trial products utilizing prescribers, pharmacies, and acentral computing station, comprising the steps of:a) forming a seriesof product trial cards by encoding on respective product trial cardsinformation that identifies a particular pharmaceutical trial product;b) issuing the product trial cards to participating prescribers; c)activating the product trial cards after issuance to prescribers by theprescribers communicatively linking the product trial cards to thecentral computing station and wherein activation is established by thecentral computing station verifying the authenticity of the producttrial cards, recording selected information encoded on the product trialcards in a database associated with the central computing station, andfinally approving activation; d) transferring a respective activatedproduct trial card from a prescriber to a patient; e) the patient inturn presenting the activated product trial card to a participatingpharmacy; f) validating the activated product trial card at the pharmacyby the pharmacy communicatively linking the presented product trial cardwith the central computing station and verifying that the presentedproduct trial card has in fact been activated and not previouslyvalidated; g) after validating the presented product trial card, thepharmacy then dispensing the approved pharmaceutical trial product tothe patient; and h) periodically accounting to the participatingpharmacies for pharmaceutical trial product dispensed in accordance withthe records of the database associated with the central computingsystem.
 2. The method of claim 1 wherein the product trial cards whendelivered to a prescriber are in an unactivated state and wherein theactivation of the product trial cards takes place while said cards arein the possession of a prescriber.
 3. The method of claim 2 furtherincluding the step of issuing an authorization card to the participatingprescribers and wherein activation of the product trial card isconditioned upon respective prescribers establishing authorization. 4.The method of claim 3 including the step of establishing prescriberauthorization by communicatively linking a prescriber's authorizationcard with the central computing station and verifying the authenticityof the prescriber's authorization card.
 5. The method of claim 4 whereinthe product trial cards are activated after prescriber authorization hasbeen established and wherein the product trial cards are activated bycommunicatively linking the respective cards with the central computingstation wherein the product trial cards are authenticated and encodedinformation associated with the respective product trial cards arerecorded in a database associated with the central computing station. 6.The method of claim 5 wherein the step of activating the product trialcards includes issuing to the prescriber an approval code for eachproduct trial card activated.
 7. The method of claim 6 including thestep of physically recording the issued approval code for each producttrial card on the product trial card itself.
 8. The method of claim 7including the step of the prescriber signing each activated producttrial card.
 9. The method of claim 3 including the step of issuing anauthorization card to each participating pharmacy and wherein validationof the product trial cards is conditioned upon the validating pharmacyfirst establishing authorization.
 10. The method of claim 9 includingthe step of establishing pharmacy authorization by communicativelylinking a pharmacy's authorization card with the central computingstation and verifying the authenticity of the pharmacy's authorizationcard.
 11. The method of claim 10 wherein the step of validation includescommunicatively linking each product trial card presented by a patientto a pharmacy with the central computing station and verifying that thepresented product trial card has been activated and not previouslyvalidated.
 12. The method of claim 11 including the step of issuing apharmacy approval code in response to the presented product trial cardbeing validated.
 13. The method of claim 12 including the step of thepharmacy physically recording the pharmacy approval code on thepresented product trial card as a part of the validation procedure. 14.The method of claim 13 including the further step of the pharmacyactually signing the product trial card prior to or at the time ofdispensing the trial pharmaceutical product to the patient.
 15. Themethod of claim 1 including the step of accounting to the pharmacies fortrial product dispense based on the records of the database associatedwith the central computing station.
 16. The method of claim 9 wherein aprogram manager manages the distribution of pharmaceutical trial productand wherein the program manager upon receiving data stored in thedatabase associated with the central computing station then authorizesreplacement of pharmaceutical product to the individual participatingpharmacies through wholesalers.
 17. The method of claim 16 furtherincluding the step of authorizing dispensing fees to the participatingpharmacies based on the recorded pharmaceutical trial products dispensedby the pharmacies.
 18. The method of claim 1 wherein the identifyinginformation encoded on each product trial card includes product name,product size, product form and product quantity.
 19. The method of claim1 wherein the communication links between the participating prescribers,pharmacies and the central computing station are provided through a cardreader terminal, and wherein communication is established between therespective product trial cards and the central computing station by theswiping of the product trial cards through the card reader terminal. 20.The method of claim 1 wherein each participating prescriber and pharmacyhas access to a terminal that is communicatively linked to a centralcomputing station, and wherein the method includes the step of theparticipating prescribers and pharmacies entering authorizationinformation into their respective terminal and thereafter thatinformation being uploaded into the central computing station where theentered authorization information is verified prior to the respectiveprescriber establishing activation and the respective pharmaciesestablishing validation.
 21. The method of claim 20 wherein theparticipating prescribers and pharmacies are issued an authorizationmedia that is designed to be read by the respective terminals andwherein the step of entering authorization information includes the stepof the respective prescribers and pharmacies entering their respectiveauthorization media into their respective terminal and wherein encodedinformation associated with the authorization media that is stored intothe respective terminal.
 22. The method of claim 21 wherein the step ofactivating the product trial media includes entering data associatedwith the product trial media into a terminal and thereafter uploadingdata from the product trial media from the terminal to the centralcomputing station.
 23. A method of dispensing, tracking and managingpharmaceutical trial products utilizing prescribers, pharmacies, and asystem including a central computing station and database, comprisingthe steps of:a) forming a trial product media and encoding that mediawith information that identifies a particular trial pharmaceuticalproduct; b) issuing the trial product media to one or more prescribers;c) activating the trial product media by a prescriber communicativelylinking the trial product media to the central computing station whereinthe central computing station records encoded information from the trialproduct media into a database associated with the central computingstation and thereby activates the trial product media; d) the step ofactivating the product trial media including entering data associatedwith the product trial media into a terminal and thereafter uploadingdata associated with the product trial media from the terminal to thecentral computing station; e) transferring the activated product trialmedia from a prescriber to a patient; f) the patient then presenting theactivated product trial media to a pharmacy; g) validating the producttrial media at the pharmacy by communicatively linking the presentedproduct trial media with the central computing station which determinesif the presented product trial media has in fact been activated by aprescriber and if activated, the central computing station approvesdispensing of the pharmaceutical product identified and authorized bythat product trial media; h) the step of validating the product trialmedia including entering data from the activated product trial mediainto a terminal and uploading that data from the terminal to the centralcomputing station; i) after validating the presented product trialmedia, dispensing the approved pharmaceutical trial product to thepatient; and j) periodically accounting to the participating pharmaciesfor pharmaceutical trial product dispensed in accordance with therecords of the database associated with the central computing station.24. The method of claim 23 wherein activation of the product trial mediais conditioned upon the activating prescriber being an authorizedprescriber, and wherein validation and dispensing of the pharmaceuticaltrial product is conditioned upon the validating and dispensing pharmacybeing an authorized pharmacy.
 25. The method of claim 24 whereinauthorization for both prescribers and pharmacies is established in partat least by issuing a uniquely identifying authorizing media to eachparticipating prescriber and pharmacy and wherein the step ofauthorization entails prescribers and pharmacies establishing acommunication link between the issued authorizing media and the centralcomputing station wherein the central computing station effectivelyscans the issued authorizing media so as to authenticate the same. 26.The method of claim 25 wherein participating prescribers and pharmaciesare provided with a communication terminal for communicating with thecentral computing station, and wherein prescriber and pharmacyauthorization is further conditioned upon the initialization of thecommunication terminal associated with respective prescribers andpharmacies.
 27. The method of claim 23 including recording in thedatabase associated with the central computing station selected encodedinformation associated with the product trial media both during theactivating and validating steps of the method.
 28. The method of claim23 including the step of issuing authorizing media to participatingprescribers and pharmacies and wherein the authorizing media includesencoded identifying information that identifies particular prescribersand pharmacies, and wherein the steps of activating and validating theproduct trial media include recording in the database associated withthe central computing station encoded information on the authorizingmedia of the prescribers and pharmacies.
 29. The method of claim 28including the step of conditioning the activating step on the prescribercommunicating a unique identification code to the central computingstation and further conditioning the validating step on the pharmacycommunicating a unique identification code to the central computingstation.
 30. The method of claim 28 wherein the system further includesa series of terminals located at prescriber and pharmacy sites with eachterminal being communicatively linked to the central computing stationand wherein both the activating and validating steps of the method areconditioned upon the initialization of the terminal of any participatingprescriber and pharmacy.